Systems and methods for calculating patient dosage

ABSTRACT

Systems and methods for providing a dosage on a device comprising an electronic circuit, an input device, and a display screen. The method includes receiving an input signal of a user indicating an input directed to a patient sex and patient status selected from the group comprising new patient, returning patient and booster patient. If the patient sex is female, an effective estradiol dosage and an effective testosterone dosage are determined using dosage calculation methods selected based on the patient status and additional female input parameters. If the patient sex is male an effective testosterone dosage is determined using dosage calculation methods selected based on the patient status and additional male input parameters.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/721,949 filed on Dec. 20, 2012 and entitled “SYSTEMS AND METHODS FORCALCULATING PATIENT DOSAGE.” This application also claims priority to,and is a continuation of, U.S. patent application Ser. No. 13/548,714,filed Jul. 13, 2012, which claims priority to U.S. Provisional PatentApplication No. 61/507,318, filed on Jul. 13, 2011, the disclosures ofwhich are incorporated herein by reference in their entireties.

BACKGROUND

1. Statement of the Technical Field

Embodiments include systems and methods for determining the mosteffective and safe dosage for hormone replacement therapy.

2. Description of the Related Art

Hormone replacement therapy includes estradiol and testosterone forfemales and testosterone for males. Traditionally, determination ofrecommended dosage for hormone replacement therapy requires that aphysician consider numerous factors, including patient age,weight/height, health conditions, contraindications, hormonal levels,previous and current medications, and the like. In all, a properdetermination involves correct consideration and weighing of manyfactors, some of which the physician may not even have easy access to,such as a patient's detailed health record.

Systems and methods for automating the determination of dosage forhormone replacement therapy which take into account the relevant factorsand apply a consistent formulaic approach to minimize incorrect dosagedeterminations are desirable.

SUMMARY

Systems and methods for providing a dosage on a device comprising anelectronic circuit, an input device, and a display screen are provided.The methods include receiving, from the input device, an input signal ofa user indicating an input directed to a patient sex and patient status,wherein patient status is selected from the group including new patient,returning patient and booster patient. If the patient sex is female, theelectronic circuit determines an effective estradiol dosage and aneffective testosterone dosage using dosage calculation methods selectedbased on the patient status and additional female input parameters. Ifthe patient sex is male, the electronic circuit determines an effectivetestosterone dosage using dosage calculation methods selected based onthe patient status and additional male input parameters. The determinedeffective dosages may then be displayed on the display screen.

In an aspect of the invention, the additional female input parametersinclude age, height, weight, race, number of pregnancies, number of livebirths, number of abortions, history of renal disease, active liverdisease, hysterectomy, history of cervical cancer, history of ovariancancer, fibrocystic breast disease, history of breast cancer, currentfollicle stimulating hormone (FSH) level, current testosterone level,current estradiol level, current non-pellet estrodiol dose, history ofacne or facial hair, history of hair loss, history of PCOS, history ofhysterectomy, history of heavy menses and history of metabolic syndrome.

In additional aspects, the dosage determination for a female new patientfurther includes the electronic circuit receiving patient age andweight, determining patient weight/age ratio, looking up predetermineddosage values based on weight/age estradiol, weight testosterone, ageestradiol, testosterone level, follicle stimulating hormone (FSH) level,and a current dose. The electronic circuit then determines a problemfactor adjustment and an FSH adjustment, wherein the FSH adjustment is12.5 mg if the patient age is greater than or equal to 30 years. Theelectronic circuit next determines an estradiol dosage according to:

estradiol dosage=((weight/age estradiol ratio lookup+age estradiollookup+FSH lookup)×problem factor adjustment)+FSH adjustment

and a testosterone dosage according to:

testosterone dosage=(weight testosterone ratio lookup+testosterone levellookup)×testosterone age lookup.

A further aspect of the invention provides the problem factor adjustmentas a value determined to be the multiplicative product of the one ormore values selected from the group comprising:

1.00 for no problem adjustment,

0.90 for patient history of acne or facial hair,

0.88 for history of hair loss,

0.75 for history of PCOS,

0.88 for hysterectomy,

0.70 for history of fibrocystic breast disease,

0.88 for history of heavy menses,

0.80 for persistent breast pain,

0.80 for mid-cycle bleeding,

0.75 for headaches,

0.75 for fluid retention, and

0.00 for history of metabolic syndrome.

A further aspect provides a dosage determination method for a femalereturning patient further, in which the electronic circuit receives thepatient age and weight, and determines the patient weight/age ratio.Next the electronic circuit looks up predetermined values in tablesweight/age estradiol value, a weight testosterone value, an ageestradiol value, a current estradiol dose value, a testosterone levelvalue, a follicle stimulating hormone (FSH) value, and a current dosevalue. The electronic circuit may also determine a returning femaleproblem factor adjustment such as:

1.00 for no problem adjustment,

0.90 for history of acne or facial hair,

0.88 for history of hair loss,

0.75 for history of PCOS,

0.88 for hysterectomy,

0.70 for history of fibrocystic breast disease,

0.88 for history of heavy menses,

0.80 for persistent breast pain,

0.80 for mid-cycle bleeding,

0.75 for headaches,

0.75 for fluid retention, and

0.00 for history of metabolic syndrome.

The electronic circuit then determines an estradiol dosage according to:

estradiol dosage=(weight/age estradiol ratio lookup+age estradiollookup+FSH lookup+current estradiol dose lookup)×problem factoradjustment,

and, a testosterone dosage according to:

testosterone dosage=(weight testosterone ratio lookup+testosterone levellookup)×testosterone age lookup.

In another aspect of the invention, the electronic circuit determinesthe dosage female booster patient by receiving information such aspatient previous estradiol dosage, previous testosterone dosage, whetherpatient is pre-menopausal, estradiol level, and whether patient hasmigraines, and then, if patient is not pre-menopausal, or ispre-menopausal with estradiol level less than 10 or migraines, anestradiol dosage is determined according to:

estradiol dosage=previous estradiol dosage/2.00.

Otherwise, if the patient is pre-menopausal, estradiol is greater thanor equal to 10 or patient has migraines, estradiol dosage=0. Also,testosterone dosage for a booster patient is determined according to:

testosterone dosage=previous testosterone dosage/3.00.

Also provided in an aspect of the invention, additional male inputparameters for testosterone dosing include patient age, height, weight,race, history of hypertension, history of diabetes, history of coloncancer, history of testicular cancer, history of BPH, history ofprostate cancer, history of renal disease, active liver disease, andcurrent testosterone level. The electronic circuit receives patient age,height, weight, race, history of hypertension, history of diabetes,history of colon cancer, history of testicular cancer, history of BPH,history of prostate cancer, history of renal disease, active liverdisease and current testosterone level, and then looks up predeterminedvalues such as a weight lookup value, an age lookup value, and a currentdose lookup value. Next, the electronic circuit determines an additionaladjustment factor according to:

1.00 for no problem adjustment,

0.95 for history of BPH,

0.90 for history of prostate cancer,

0.90 for history of both prostate cancer and BPH, ignoring individualvalues for these conditions, and

0.00 if patient testosterone level greater than 700.

The electronic circuit then determines a male patient testosteronedosage according to:

testosterone dosage=weight lookup value×age lookup value×additionaladjustment.

The determined testosterone dosage may then be modified as follows:

history of diabetes, dosage=dosage+100 mg;

sedentary patient, dosage=dosage−100 mg;

patient exercises five times/week or more,dosage=dosage+100 mg; and

patient uses a testosterone gel 1.62% or greater, dosage=dosage−100 mg.

For male return patients, if the current testosterone dosage is lessthan 400.00 mg, then the new dosage=previous testosterone dosage+200.00mg, otherwise the new dosage remains the same as the previous dosage.

In addition, in another aspect of the invention, the electronic circuitdetermines the testosterone dosage for a male booster patient asfollows:

-   -   booster dosage=previous testosterone dosage+0.20 mg×additional        adjustment; where additional adjustment is determined as the        multiplicative product of the one or more values selected from        the group including:    -   0.00 for no problem adjustment,    -   0.95 for history of BPH,    -   0.90 for history of prostate cancer,    -   0.90 for history of both prostate cancer and BPH, ignoring        individual values for these conditions, and    -   0.00 if testosterone level greater than 700.

Also disclosed are devices including a non-transient computer readablemedium incorporating computer instructions including theabove-referenced methods.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will be described with reference to the following drawingfigures, in which like numerals represent like items throughout thefigures, and in which:

FIG. 1 is a schematic system diagram of an exemplary system that isuseful for understanding the present invention.

FIG. 2 is a block diagram of an exemplary communication device that isuseful for understanding the present invention.

FIG. 3 is a block diagram of an exemplary server that is useful forunderstanding the present invention.

FIG. 4 provides a flow diagram of an exemplary implementation that isuseful for understanding the present invention.

FIG. 5 provides a flow diagram of an exemplary implementation that isuseful for understanding the present invention.

DETAILED DESCRIPTION

The present invention is described with reference to the attachedfigures. The figures are not drawn to scale and they are provided merelyto illustrate the instant invention. Several aspects of the inventionare described below with reference to example applications forillustration. It should be understood that numerous specific details,relationships, and methods are set forth to provide a full understandingof the invention. One having ordinary skill in the relevant art,however, will readily recognize that the invention can be practicedwithout one or more of the specific details or with other methods. Inother instances, well-known structures or operation are not shown indetail to avoid obscuring the invention. The present invention is notlimited by the illustrated ordering of acts or events, as some acts mayoccur in different orders and/or concurrently with other acts or events.Furthermore, not all illustrated acts or events are required toimplement a methodology in accordance with the present invention.

The word “exemplary” is used herein to mean serving as an example,instance, or illustration. Any aspect or design described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other aspects or designs. Rather, use of the wordexemplary is intended to present concepts in a concrete fashion. As usedin this application, the term or is intended to mean an inclusive orrather than an exclusive “or”. That is, unless specified otherwise, orclear from context, “X employs A or B” is intended to mean any of thenatural inclusive permutations. That is if, X employs A; X employs B; orX employs both A and B, then “X employs A or B” is satisfied under anyof the foregoing instances.

The present invention concerns implementing systems and methods fordetermining the most effective and safe dosage for hormone replacementtherapy. While the specific implementations described herein aredirected to determining dosage for hormone replacement therapy, it isenvisioned that the systems and methods described herein can be usedwith minor modification for determining recommended dosage in otherdrug-related health areas, without limitation.

SOTTOPELLE™ hormone replacement therapy (“HRT”) using Hormone PelletTherapy is a highly effective form of HRT. This treatment method isbased on prescribing the right kind of hormone (e.g., biologicallyidentical), in the correct amounts (e.g., determined through testing &proper analysis of the results), using the right delivery system (e.g.,pellets).

A crucial element to effective HRT is determining and providing theproper dosage of hormones to the patient. Correct dosing requiresprocesses that consider numerous factors, the proper mathematicalweighting of those factors, as well as significant input from thepatient history and other related elements. These processes, tables,factors and related items for calculation of proper dosages forSOTTOPELLE™ HRT are described herein.

The present invention provides a system and method for calculating HRTdosage, in particular for calculation of SOTTOPELLE™ HRT dosage. Theprocesses, tables and factors and related items described herein areadvantageously incorporated onto a system having at a minimum anelectronic circuit and related electronic memory, as well as input/outdevices controlled by the electronic circuit. The processor and memoryare configured to interface with a user through the input/output devicesto obtain the information needed to apply the processes, tables, factorsand related items described herein and further configured to determinethe correct dosage for SOTTOPELLE™ HRT. A database is also envisioned tobe accessible by the electronic circuit and to store data regarding thepatient, patient test results, prior dosing information, prior sideeffects, and any other medically significant information. The electroniccircuit may then access the database for information and may also storeinformation therein.

Although described in terms of various components used to implement themethods, the present invention can be used in a variety of systemconfigurations, such as, but not limited to, mobile phone applications,portable computer applications, PDA applications, and the like. Also,various system components may be combined into a few or even onehardware component(s) without affecting overall functionality. Exemplaryimplementing system embodiments of the present invention will bedescribed below in relation to FIGS. 2-3. Exemplary method embodimentsof the present invention will be described below in relation to FIGS.4-5.

Exemplary Systems Implementing the Present Invention

Referring now to FIG. 1, there is provided a block diagram of anexemplary system 100 that is useful for understanding variousembodiments of the present invention. The system 100 comprisescommunication device 102, a network 104, a user interface (UI)presentation server 108, an application server 106, a cache server 112,and a database 114. Also depicted is a physician user 110, forillustrative purposes. The system 100 may include more, less ordifferent components than those illustrated in FIG. 1. However, thecomponents shown are sufficient to disclose an illustrative embodimentimplementing the present invention. In particular, the functionality ofthe UI presentation server 108, application server 106, and cache server112 may be combined into one or two servers in various embodimentswithout affecting the efficacy of the invention. Also, servers 106, 108and 112 may include identical components or may differ in composition,and are described generically herein as “server 106, 108, 112”.

In an embodiment, the UI presentation server provides the user interfaceto the communication device 102 over the Internet 104. Information inputthrough the communication device 102 is forwarded to the applicationserver 106 for processing and/or storage in the database 114. The cacheserver 112 saves frequently-used data for fast access as needed.

The database 114 component may be a stand-alone database server, apersistent drive and operating software associated with the applicationserver 106, a cloud-computing database “cloud”, or may be implemented byother means.

The communication device 102 is configured to communicate with a server108 over a network 104 to send and obtain information regarding apatient. This information can include, but is not limited to,information needed for enabling the determination of recommended dosagesfor hormone replacement therapy.

Referring now to FIG. 2, there is provided a more detailed block diagramof the communication device 102. The communication device 102 will bedescribed herein as comprising a mobile phone or a smart phone. However,the present invention is not limited in this regard. For example, thecommunication device can alternatively comprise a PDA, a tablet PersonalComputer (“PC”), or the like.

Notably, the communication device 102 can include more or lesscomponents than those shown in FIG. 2. For example, the communicationdevice 102 can include a wired system interface, such as a universalserial bus interface (not shown in FIG. 2). However, the componentsshown are sufficient to disclose an illustrative embodiment implementingthe present invention.

As shown in FIG. 2, the communication device 102 comprises an antenna202 for receiving and transmitting Radio Frequency (RF) signals. Areceive/transmit (Rx/Tx) switch 204 selectively couples the antenna 202to the transmitter circuitry 206 and receiver circuitry 208 in a mannerfamiliar to those skilled in the art. The receiver circuitry 208demodulates and decodes the RF signals received from a network (e.g.,the network 104 of FIG. 1) to derive information therefrom. The receivercircuitry 208 is coupled to a controller 210 via an electricalconnection 234. The receiver circuitry 208 provides the decoded RFsignal information to the controller 210. The controller 210 uses thedecoded RF signal information in accordance with the function(s) of thecommunication device 102. The controller 210 also provides informationto the transmitter circuitry 206 for encoding and modulating informationinto RF signals. Accordingly, the controller 210 is coupled to thetransmitter circuitry 206 via an electrical connection 238. Thetransmitter circuitry 206 communicates the RF signals to the antenna 202for transmission to an external device (e.g., network equipment ofnetwork 104 of FIG. 1).

The controller 210 stores the decoded RF signal information in a memory212 of the communication device 102. Accordingly, the memory 212 isconnected to and accessible by the controller 210 through an electricalconnection 232. The memory 212 can be a volatile memory and/or anon-volatile memory. For example, the memory 212 can include, but is notlimited to, a Random Access Memory (RAM), a Dynamic Random Access Memory(DRAM), a Static Random Access Memory (SRAM), Read-Only Memory (ROM) andflash memory. The memory 212 can also have stored therein the softwareapplications 252 and user-defined rules 254.

The software applications 252 may include, but are not limited to,applications operative to provide telephone services, networkcommunication services, Internet connectivity and access services,commerce services, email services, web based services, and/or electroniccalendar services.

As shown in FIG. 2, one or more sets of instructions 250 are stored inthe memory 212. The instructions 250 can also reside, completely or atleast partially, within the controller 210 during execution thereof bythe communication device 102. In this regard, the memory 212 and thecontroller 210 can constitute non-transient machine-readable media. Theterm “machine-readable media”, as used here, refers to a single mediumor multiple media that store the one or more sets of instructions 250.The term “machine-readable media”, as used here, also refers to anymedium that is capable of storing, encoding or carrying the set ofinstructions 250 for execution by the communication device 102 and thatcause the communication device 102 to perform one or more of themethodologies of the present disclosure.

The controller 210 is also connected to a user interface 230. The userinterface 230 is comprised of input devices 216, output devices 224, andsoftware routines (not shown in FIG. 5) configured to allow a user tointeract with and control software applications 252 installed on thecomputing device 102. Such input and output devices respectivelyinclude, but are not limited to, a display 228, a speaker 226, a keypad220, a directional pad (not shown in FIG. 5), a directional knob (notshown in FIG. 2), a microphone 222, a Push-To-Talk (“PTT”) button 218,sensors 240, a camera 242 and a Radio Frequency Identification (“RFID”)reader 244.

Referring now to FIG. 3, there is provided a more detailed block diagramof a server 106, 108, 112 of FIG. 1 that is useful for understanding thepresent invention. As shown in FIG. 3, the server 106, 108, 112comprises a system interface 322, a user interface 302, a CentralProcessing Unit (CPU) 306, a system bus 310, a memory 312 connected toand accessible by other portions of server 108 through system bus 310,and hardware entities 314 connected to system bus 310. At least some ofthe hardware entities 314 perform actions involving access to and use ofmemory 312, which can be a Random Access Memory (RAM), a disk driverand/or a Compact Disc Read Only Memory (CD-ROM). Some or all of thelisted components 302-322 can be implemented as hardware, softwareand/or a combination of hardware and software. The hardware includes,but is not limited to, an electronic circuit.

The server 106, 108, 112 may include more, less or different componentsthan those illustrated in FIG. 3. However, the components shown aresufficient to disclose an illustrative embodiment implementing thepresent invention. The hardware architecture of FIG. 3 represents oneembodiment of a representative server configured to provide supportingservices to a user of a communication device (e.g., communication device102 of FIG. 1). For example, the server 106, 108, 112 may implement amethod for lookup of available auctions using an external database incommunication with the server 106, 108, 112 (database not depicted), orthe server may use its existing disk drive unit 316, computer-readablestorage medium 318 and other facilities to store auction information, asneeded. It may also provide dosage factor data to the communicationdevice 102, as needed. Exemplary embodiments of said method will bedescribed below in relation to FIGS. 4-5.

Hardware entities 314 can include microprocessors, Application SpecificIntegrated Circuits (ASICs) and other hardware. Hardware entities 314can include a microprocessor programmed for facilitating the provisionof the automatic software function control services to a user of thecommunication device (e.g., communication device 102 of FIG. 1). In thisregard, it should be understood that the microprocessor can access andrun various software applications (not shown in FIG. 3) installed on theserver 106, 108, 112. Such software applications include, but are notlimited to, database applications.

As shown in FIG. 3, the hardware entities 314 can include a disk driveunit 316 comprising a computer-readable storage medium 318 on which isstored one or more sets of instructions 320 (e.g., software code or codesections) configured to implement one or more of the methodologies,procedures, or functions described herein. The instructions 320 can alsoreside, completely or at least partially, within the memory 312 and/orwithin the CPU 306 during execution thereof by the server 108. Thememory 312 and the CPU 306 also can constitute machine-readable media.The term “machine-readable media”, as used here, refers to a singlemedium or multiple media (e.g., a centralized or distributed database,and/or associated caches and servers) that store the one or more sets ofinstructions 320. The term “machine-readable media”, as used here, alsorefers to any medium that is capable of storing, encoding or carrying aset of instructions 320 for execution by the server 106, 108, 112 andthat cause the server 106, 108, 112 to perform any one or more of themethodologies of the present disclosure.

Exemplary Methods

Referring now to FIGS. 4-5, there is provided a series of diagrams thatillustrate methods for determining the most effective and safe dosagefor hormone replacement therapy. Exemplary embodiments of the inventionare presented in FIGS. 4-5 with respect to methods for calculatinghormone replacement therapy (HRT) dosage, in particular for calculationof SOTTOPELLE™ HRT dosage. References to “HRT” in the descriptions toFIGS. 4-5 herein are understood to specifically refer to SOTTOPELLE™HRT, unless otherwise indicated. It is understood that the tables,lookup values, factors used in these embodiments may vary depending onseveral variables, such as but not limited to therapy regimens, drugused, drug concentration, absorption, efficacy, and the like.

Although use of a communication device 102, as described in FIG. 2, ispresented herein, the present invention is not limited in this regard.The methods are useful with alternative devices as well, such asportable computer applications, PDA applications, and tablet computingdevices, and the like. The methods described in FIGS. 4-5 may beperformed by an electronic circuit of the communication device 102, withthe assistance of the physician 110, servers 106, 108, 112, database 114and Internet 104, consistent with an embodiment of the invention.

As shown in FIG. 4, the method 400 begins with step 402, with thedetermination of patient type. FIG. 4 is generally applicable to femalepatients, whereas FIG. 5 is generally applicable to male patients. Forexemplary purposes, the patient types are: 1. Female New Patient—Afemale patient that has never been treated with HRT; 2. Female ReturnPatient—A female patient that has been treated with HRT and is returningfor ongoing treatment; 3. Female Booster Patient—A female patient thathas been treated with HRT needing an additional dose prior to their nextdose; 4. Male New Patient—A male patient that has never been treatedwith HRT; 5. Male Return Patient—A male patient that has been treatedwith HRT and is returning for ongoing treatment; and, 6. Male BoosterPatient—A male patient that has been treated with HRT needing anadditional dose prior to their next dose.

At step 402, the electronic circuit determines the patient type. In anembodiment of the invention, the physician 110 inputs the patient typedirectly into the communication device 102. Alternatively, the patienttype may be determined from the patient name and/or a uniqueidentification number combined with a lookup of patient informationstored in a database 114.

For a Female New Patient, step 402 proceeds to 403, and then to step406, where input parameters are input. These parameters may includepatient age, height, weight, race, number of pregnancies, number of livebirths, number of abortions, history of renal disease, active liverdisease, history of hysterectomy, history of cervical cancer, history ofovarian cancer, history of fibrocystic breast disease, history of breastcancer, current follicle stimulating hormone (FSH) level, currenttestosterone level, current estradiol level, current non-pelletestradiol dose, history of acne or facial hair, history of hair loss,history of PCOS, history of heavy menses and history of metabolicsyndrome.

Next, at step 408, various lookup tables are consulted by the electroniccircuit to determine various factors for estradiol and testosteronedosage calculation as well as dosage adjustment factors for variousconditions and problems. Exemplary lookup tables used in an embodimentof the invention for female patients include Female Estradiol Weight/Age(Table 1), Female Estradiol Age (Table 2), Female Estradiol FSH (Table3), Female Testosterone Weight (Table 4), Female Testosterone Age (Table5), Female Testosterone Testosterone (Table 6), Conjugated Estrogen,Estradiols Pills, Estradiol Patch, Biestradiol Cream or Tabs, andProblem Factor. Exemplary tables used for HRT follow:

TABLE 1 Female Estradiol Weight/Age Weight/Age Ratio (lbs/Years) LookupValue (mg)   0-1.5 1 1.6-2.5 2 2.6-3.9 3 >4 2

TABLE 2 Female Estradiol Age Age (Years) Lookup Value <40 3 40-50 551-60 15 61-68 12.5 >68 4

TABLE 3 Female Estradiol FSH FSH Lookup Value <31  0 31-50 1  51-1002 >100 3

TABLE 4 Female Testosterone Weight Weight (lbs.) Lookup Value (mg) 75-150 75 151-200 87.5 >200 100

TABLE 5 Female Testosterone Age Age (Years) Lookup Value 0-67 1 >67 0.63

TABLE 6 Female testosterone Testosterone Testosterone Lookup Value (mg)0-20 37.5 21-100 25 >100 0

After obtaining the lookup values from the various tables in step 408,additional problem adjustment factors are determined in step 410,disease history is factored in step 412, and other adjustments aredetermined in step 414. In an embodiment of the invention, these variousconsiderations may include, but are not limited to: Female EstradiolProblem Factor, Conjugated Estrogen, Estradiols Pills, Estradiol Patch,Biestradiol Cream or Tabs, and Problem Factor. Exemplary adjustmentfactors applied to the dosage determined after application of the lookupvalues to the base dosage, i.e., “test dosage” may include, but are notlimited to: for history of acne or facial hair, dosage=test dosage×0.90;history of hair loss, dosage=test dosage×0.88; hysterectomy, if YES,dosage=test dosage×0.88; history of PCOS, dosage=test dosage×0.75;history of heavy menses, if YES, dosage=test dosage×0.88; history ofmetabolic syndrome, if YES, DO NOTHING; persistent breast pain, if YES,dosage=test dosage×0.80; mid-cycle bleeding, if YES, dosage=testdosage×0.80; headache, if YES, dosage=test dosage×0.75; fluid retention,if YES, dosage=test dosage×0.75; and, fibrocystic breast disease, ifYES, dosage=test dosage×0.70. Also, if the FSH is >=30 and age isbetween 20 and 50 years, then the FSH adjustment lookup value is set to12.5.

Next, at step 416, formula are applied to determine female dosage forestradiol and testosterone. Female dosage calculations involve twocalculations, one for extradiol and the other for testosterone. Theestradiol calculation involves calculating the weight/age ratio, age,current FSH levels, a problem factor multiplier and an FSH adjustmentfactor. The weight/age ratio is calculated by dividing the weight inlbs. by the age in years. As indicated above, the weight/age ratio isthen used to lookup the weight/age ratio lookup value from Table 1. Theage is then used to lookup the lookup value in the Female Estradiol Agelookup table (Table 2). The value of the current FSH level is then usedto find the corresponding lookup value in the Female Estradiol FSHlookup table (Table 3). These values are then summed into a single valueand then multiplied by any problem factor adjustment values, and addedto the calculation. The estradiol dosage is thus calculated as:

Estradiol dosage=((Weight Age Ratio Lookup+Age Lookup+FSHLookup)×Problem Factor)+FSH Adjustment

Similarly, the testosterone calculation involves calculating the weightlookup value, current testosterone level lookup value and testosteroneage lookup value. The weight is used to obtain a value from the FemaleTestosterone Weight lookup table (Table 4). The current testosteronelevel is used to obtain a value in the Female Testosterone Testosteronelookup table (Table 5). These two values are then summed. The age isused to obtain a value in the Female Testosterone Age lookup table(Table 6). The obtained testosterone age lookup value is then multipliedby the sum of the testosterone weight and testosterone testosteronelookup values. The testosterone dosage is thus calculated as:

Testosterone dosage=(Weight Testosterone Lookup+Testosterone LevelLookup)×Testosterone Age Lookup

Exception logic applies at step 420 at the physician's discretion forpre-menopausal women: pre-menopausal females do not get estradiol exceptin the case where current estradiol level is <10 or if they exhibitsymptoms of migraines. For pre-menopausal women without estradiol level<10 or migraines, estradiol calculated dose becomes 0.00. The process iscomplete at step 422, with final dosage determination.

Like the dosage calculations for female new patients, female returndosage calculations also involve two components: one for estradiol andthe other for testosterone. The method includes all the steps includedfor a new patient, and also step 407 interposed immediately after step406. In step 407, the patient's previous dosage of estradiol isdetermined. This previous dosage may be directly input or may be savedin a database. The female return patient estradiol dosage is thencalculated at step 416 using the following formula:

Estradiol dosage=((Weight Age Lookup+Age Lookup+FSH Lookup+Current DoseLookup)×Problem Factor)

Female Return Testosterone dosage is calculated using the followingformula:

Testosterone dosage=(Weight Testosterone Lookup+Testosterone LevelLookup)×Testosterone Age Lookup

Calculation of female booster dosages for estradiol and testosterone isdetermined in step 416, respectively, by taking the previous estradioldosage and dividing by 2.00, and taking the previous testosterone dosageand dividing by 3.00.

Referring now to FIG. 5, methods of determining dosage for male patientsis presented. At step 502, the electronic circuit determines the patienttype. In an embodiment of the invention, the physician 110 inputs thepatient type directly into the communication device 102. Alternatively,the patient type may be determined from the patient name and/or a uniqueidentification number combined with a lookup of patient informationstored in a database 114.

For a Male New Patient, step 502 proceeds to 503, and then to step 506,where input parameters are input. These parameters may include patientage, height, weight, race, history of hypertension, history of diabetes,history of colon cancer, history of testicular cancer, history of BPH,history of prostate cancer, history of renal disease, active liverdisease and current testosterone level. Next, at step 508, variouslookup tables are consulted to determine a base dosage for testosteroneand adjustment factors for various conditions and problems. Exemplarylookup tables used in an embodiment of the invention for male patientsinclude Male Age and Male Weight, Exemplary tables used for HRT follow:

TABLE 7 Male Age Age (Years) Lookup Value <69 1 >68 0.8

TABLE 8 Male Weight Weight (lbs.) Lookup Value (mg) <151 1200 151-1751400 176-200 1600 201-225 1800 226-250 2000 251-275 2200 276-300 2400301-350 2600 351-400 2800 >400 3000

After obtaining the lookup values from the various tables in step 508,additional problem adjustment factors are determined in step 510,disease history is factored in step 512, and other adjustments aredetermined in step 514. In an embodiment of the invention, these variousconsiderations may include, but are not limited to: Diabetes andMetabolic Syndrome. In the case of Diabetes or Metabolic Syndrome, thetestosterone dosage is increased by 100 mg. Exemplary adjustment factorsapplied to the dosage determined after application of the lookup valuesto the base dosage, i.e., “test dosage” may include, but are not limitedto: for history of BPH, dosage=test dosage×0.95; history of prostatecancer, dosage=test dosage×0.90; history of both prostate cancer andBPH, dosage=test dosage×0.90; physical activity level: sedentary/workonly, decrease dosage by 100 mg, work+exercise 5 times/week, increasedosage by 100 mg; testosterone level >=700, no treatment; monthlytestosterone injection (100-200 mg), no change in dosage; weeklytestosterone injection (100-200 mg), increase dosage by 100 mg;testosterone gel (1.62%) used, increase dosage by 100 mg.

Next, at step 516, formula are applied to determine male dosage fortestosterone HRT. Male dosage calculations involve a single calculationfor testosterone. The testosterone calculation involves calculating theweight lookup value, age lookup value, obtaining the currenttestosterone dose value, if any, and applying any additional adjustments(from above). As indicated above, the age is used to lookup the agelookup value from Table 7. The weight is then used to lookup the lookupvalue in the Male Weight lookup table (Table 8). These values are thenmultiplied together with the applicable adjustment factor to determinethe testosterone dosage. The testosterone dosage is thus calculated as:

Testosterone dosage=Age Testosterone Lookup×Weight TestosteroneLookup×other Adjustment Multiplication Factor

Dosage calculations for male return patients are provided in step 507 byapplication of the following formula:

If Current Testosterone Dosage<400.00 mg, then

Return Testosterone dosage=previous Testosterone Dosage+200.00 mg;

Else

Return Testosterone dosage=previous Testosterone Dosage

Male booster testosterone dosage is dependent on existing or previoushistorical conditions such as BPH, cancer or combinations thereof, asincluded in the adjustment factor calculated for male new patients,above. The booster testosterone dosage is then determined as:

Booster testosterone dosage=previous testosteronedosage+(0.20×adjustment Multiplication Factor)

All of the apparatus, methods and algorithms disclosed and claimedherein can be made and executed without undue experimentation in lightof the present disclosure. While the invention has been described interms of preferred embodiments, it will be apparent to those of skill inthe art that variations may be applied to the apparatus, methods andsequence of steps of the methods without departing from the concept,spirit and scope of the invention. More specifically, it will beapparent that certain components may be added to, combined with, orsubstituted for the components described herein while the same orsimilar results would be achieved. All such similar substitutes andmodifications apparent to those skilled in the art are deemed to bewithin the spirit, scope and concept of the invention as defined.

We claim:
 1. A system for of determining a dosage of a hormone to beadministered to a patient, the system comprising: an input device; adisplay screen; and at least one electronic circuit configured to carryout the steps of: receiving an input signal from the input devicerelated to a patient sex and a patient status; selecting dosagecalculation methods to apply to the input signal, the dosage calculationmethods selected based on at least one of the patient sex, the patientstatus, and additional input parameters; calculating, using theelectronic circuit, at least one of an effective estradiol dosage and aneffective testosterone dosage based on the selected dosage calculationmethods; and displaying, on the display screen, the calculated effectivedosages.
 2. The system according to claim 1, wherein the patient statusis selected from a group comprising new patient, returning patient andbooster patient.
 3. The system according to claim 2, wherein theelectronic circuit is further configured to carry out the steps of:calculating the effective estradiol dosage and the effectivetestosterone dosage using the dosage calculation methods if the patientsex is female; and calculating the effective testosterone dosage usingthe dosage calculation methods if the patient sex is male.
 4. The systemaccording to claim 2, wherein the additional input parameters include atleast one of age, height, weight, race, number of pregnancies, number oflive births, number of abortions, history of renal disease, active liverdisease, hysterectomy, history of cervical cancer, history of ovariancancer, fibrocystic breast disease, history of breast cancer, currentfollicle stimulating hormone (FSH) level, current testosterone level,current estradiol level, current non-pellet estrodiol dose, history ofacne or facial hair, history of hair loss, history of PCOS, history ofhysterectomy, history of heavy menses and history of metabolic syndromeif the patient sex is female.
 5. The system according to claim 4,wherein the dosage method for a female new patient further comprises:receiving, by the electronic circuit, patient age and weight;determining, by the electronic circuit, patient weight/age ratio;determining, by the electronic circuit, a weight/age estradiol lookup, aweight testosterone lookup, an age estradiol lookup, a testosteronelevel lookup, a follicle stimulating hormone (FSH) lookup, and a currentdose lookup; determining, by the electronic circuit, a problem factoradjustment and an FSH adjustment, wherein the FSH adjustment is 12.5 ifage greater than or equal to 30; determining, by the electronic circuit,an estradiol dosage according to:estradiol dosage=((weight/age estradiol ratio lookup+age estradiollookup+FSH lookup)×problem factor adjustment)+FSH adjustment and,determining, by the electronic circuit, an testosterone dosage accordingto:testosterone dosage=(weight testosterone ratio lookup+testosterone levellookup)×testosterone age lookup.
 6. The system according to claim 5,wherein the electronic circuit if further configured to carry out thesteps of: setting the estradiol dosage not equal to zero if the femalepatient is pre-menopausal and exhibits at least one of a currentestradiol level less than 10 and symptoms of migraines; and setting theestradiol dosage equal to zero if the female patient is pre-menopausaland exhibits at least one of the current estradiol level greater than 10and no symptoms of migraines.
 7. The system according to claim 5,wherein the problem factor adjustment is a value determined as amultiplicative product of the one or more values selected from the groupcomprising: 1.00 for no problem adjustment, 0.90 for history of acne orfacial hair, 0.88 for history of hair loss, 0.75 for history of PCOS,0.88 for hysterectomy, 0.70 for history of fibrocystic breast disease,0.88 for history of heavy menses, 0.80 for persistent breast pain, 0.80for mid-cycle bleeding, 0.75 for headaches, 0.75 for fluid retention,and 0.00 for history of metabolic syndrome.
 8. The system according toclaim 4, wherein the dosage method for a female returning patientfurther comprises: receiving, by the electronic circuit, patient age andweight; determining, by the electronic circuit, patient weight/ageratio; determining, by the electronic circuit, a weight/age estradiollookup, a weight testosterone lookup, an age estradiol lookup, a currentestradiol dose lookup, a testosterone level lookup, a folliclestimulating hormone (FSH) lookup, and a current dose lookup;determining, by the electronic circuit, a problem factor adjustment andan FSH adjustment; determining, by the electronic circuit, an estradioldosage according to:estradiol dosage=(weight/age estradiol ratio lookup+age estradiollookup+FSH lookup+current estradiol dose lookup)×problem factoradjustment and, determining, by the electronic circuit, an testosteronedosage according to:testosterone dosage=(weight testosterone ratio lookup+testosterone levellookup)×testosterone age lookup.
 9. The system according to claim 8,wherein the problem factor adjustment is a value determined as amultiplicative product of the one or more values selected from the groupcomprising: 1.00 for no problem adjustment, 0.90 for history of acne orfacial hair, 0.88 for history of hair loss, 0.75 for history of PCOS,0.88 for hysterectomy, 0.70 for history of fibrocystic breast disease,0.88 for history of heavy menses, 0.80 for persistent breast pain, 0.80for mid-cycle bleeding, 0.75 for headaches, 0.75 for fluid retention,and 0.00 for history of metabolic syndrome.
 10. The system according toclaim 4, wherein the dosage method for a female booster patient furthercomprises: receiving, by the electronic circuit, patient previousestradiol dosage, previous testosterone dosage, whether patient ispre-menopausal, estradiol level, and whether patient has migraines; ifpatient is not pre-menopausal, or is pre-menopausal with estradiol levelless than 10 or migraines, determining, by the electronic circuit, anestradiol dosage according to:estradiol dosage=previous estradiol dosage/2.00, else if patient ispre-menopausal, estradiol is greater than or equal to 10 or patient hasmigraines, estradiol dosage=0, and, determining, by the electroniccircuit, an testosterone dosage according to:testosterone dosage=previous testosterone dosage/3.00.
 11. The systemaccording to claim 3, wherein the additional male input parameterscomprise: age, height, weight, race, history of hypertension, history ofdiabetes, history of colon cancer, history of testicular cancer, historyof BPH, history of prostate cancer, history of renal disease, activeliver disease, and current testosterone level.
 12. The system accordingto claim 11, wherein the dosage method for a male new patient furthercomprises: receiving, by the electronic circuit, patient age, height,weight, race, history of hypertension, history of diabetes, history ofcolon cancer, history of testicular cancer, history of BPH, history ofprostate cancer, history of renal disease, active liver disease andcurrent testosterone level; determining, by the electronic circuit, aweight lookup value, an age lookup value, a current dose lookup value,and an additional adjustment; determining, by the electronic circuit, antestosterone dosage according to:testosterone dosage=weight lookup value×age lookup value×additionaladjustment.
 13. The system according to claim 12, wherein the additionaladjustment is a value determined as a multiplicative product of the oneor more values selected from the group comprising: 1.00 for no problemadjustment, 0.95 for history of BPH, 0.90 for history of prostatecancer, 0.90 for history of both prostate cancer and BPH, ignoringindividual values for these conditions, and 0.0 if testosterone levelgreater than
 700. 14. The system according to claim 12, wherein thetestosterone dosage is modified as indicated for: history of diabetes,dosage=dosage+100 mg; sedentary patient, dosage=dosage−100 mg; patientexercises five times/week or more, dosage=dosage+100 mg; patient uses atestosterone gel 1.62% or greater, dosage=dosage−100 mg.
 15. The systemaccording to claim 11, wherein the dosage calculation method for a malereturn patient further comprises: if current testosterone dosage is lessthan 400.00 mg, then dosage=previous testosterone dosage+200.00 mg;else, dosage=previous testosterone dosage.
 16. The system according toclaim 11, wherein the dosage calculation method for a male boosterpatient further comprises: determining, by the electronic circuit, anadditional adjustment value determined as a multiplicative product ofthe one or more values selected from the group comprising: 1.00 for noproblem adjustment, 0.95 for history of BPH, 0.90 for history ofprostate cancer, 0.90 for history of both prostate cancer and BPH,ignoring individual values for these conditions, and 0.0 if testosteronelevel greater than 700; determining a testosterone dosage as:previous testosterone dosage+0.20 mg×additional adjustment.
 17. A methodof providing a dosage on a device comprising an electronic circuit, aninput device, and a display screen, the method comprising: receiving aninput signal from the input device related to a patient sex and apatient status; selecting dosage calculation methods to apply to theinput signal, the dosage calculation methods selected based on at leastone of the patient sex, the patient status, and additional inputparameters; calculating, using the electronic circuit, at least one ofan effective estradiol dosage and an effective testosterone dosage basedon the selected dosage calculation methods; and displaying, on thedisplay screen, the calculated effective dosages.
 18. The methodaccording to claim 17, wherein selecting the dosage calculation methodsbased on additional input parameters includes selecting at least one ofage, height, weight, race, number of pregnancies, number of live births,number of abortions, history of renal disease, active liver disease,hysterectomy, history of cervical cancer, history of ovarian cancer,fibrocystic breast disease, history of breast cancer, current follicalstimulating hormone (FSH) level, current testosterone level, currentestradiol level, current non-pellet estradiol dose, history of acne orfacial hair, history of hair loss, history of PCOS, history ofhysterectomy, history of heavy menses and history of metabolic syndromeif the patient sex is female.
 19. The method according to claim 18,wherein selecting the dosage calculation method for a female new patientfurther comprises: receiving, by the electronic circuit, patient age andweight; determining, by the electronic circuit, patient weight/ageratio; determining, by the electronic circuit, a weight/age estradiollookup, a weight testosterone lookup, an age estradiol lookup, atestosterone level lookup, a follicle stimulating hormone (FSH) lookup,and a current dose lookup; determining, by the electronic circuit, aproblem factor adjustment and an FSH adjustment, wherein the FSHadjustment is 12.5 if age greater than or equal to 30; determining, bythe electronic circuit, an estradiol dosage according to:estradiol dosage=((weight/age estradiol ratio lookup+age estradiollookup+FSH lookup)×problem factor adjustment)+FSH adjustment and,determining, by the electronic circuit, an testosterone dosage accordingto:testosterone dosage=(weight testosterone ratio lookup+testosterone levellookup)×testosterone age lookup.
 20. The method according to claim 18,wherein selecting the dosage calculating methods for a female boosterpatient further comprises: receiving, by the electronic circuit, patientprevious estradiol dosage, previous testosterone dosage, whether patientis pre-menopausal, estradiol level, and whether patient has migraines;if patient is not pre-menopausal, or is pre-menopausal with estradiollevel less than 10 or migraines, determining, by the electronic circuit,an estradiol dosage according to:estradiol dosage=previous estradiol dosage/2.00, else if patient ispre-menopausal, estradiol is greater than or equal to 10 or patient hasmigraines, estradiol dosage=0, and, determining, by the electroniccircuit, an testosterone dosage according to:testosterone dosage=previous testosterone dosage/3.00.